Learning Objectives and CME/Disclosure Information

This activity is intended for healthcare providers delivering care to women and their families.

After completing this activity, the participant should be better able to:

1. Compare and contrast the recommendations from ACOG and SMFM regarding the use of insulin or metformin as a preferred therapy for GDM2. Recall important changes in the 2018 updated ACOG GDM recommendations

Estimated time to complete activity: 0.25 hours

Faculty:

Disclosure of Conflicts of Interest

Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. PIM is committed to providing its learners with high quality CME activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.

Method of Participation and Request for Credit

Fees for participating and receiving CME credit for this activity are as posted on The ObG Project website. During the period from March 4 2018 through March 3 2019, participants must read the learning objectives and faculty disclosures and study the educational activity.

If you wish to receive acknowledgment for completing this activity, please complete the post-test and evaluation. Upon registering and successfully completing the post-test with a score of 100% and the activity evaluation, your certificate will be made available immediately.

For Pharmacists: Upon successfully completing the post-test with a score of 100% and the activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service within 4 weeks.

Joint Accreditation Statement

In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and The ObG Project. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

Physician Continuing Medical Education

Postgraduate Institute for Medicine designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

SUMMARY:

The SMFM released a statement on the use of metformin as a first-line alternative to insulin in women with GDM. ACOG has also released an update to the major 2017 Practice Bulletin which also addresses this issue and still considers insulin the preferred option to treat women who are not adequately controlled with appropriate nutritional therapy.

Both the ACOG update and SMFM statement summarize the literature, including recent meta-analyses on the comparison studies between insulin and metformin

Data has been conflicting based on whether non-published studies and women with women with type II diabetes are included

Some studies have demonstrated a higher risk for preterm birth (but lower for gestational hypertension) in the metformin group while other studies have not identified a difference in preterm birth

ACOG

Based on current evidence, ACOG states that, consistent with ADA guidance, insulin is the ‘preferred’ approach for GDM for women not sufficiently controlled with diet and exercise

In addition, the ACOG update states

Thus, although metformin may be a reasonable alternative approach to treat gestational diabetes, it is important to counsel women about the lack of superiority when compared with insulin, the placental transfer of the drug, and the absence of long-term data in exposed offspring. Additionally, in the aforementioned prospective trials, between 26% and 46% of women who took metformin alone eventually required insulin.

SMFM

Upon review of the evidence, SMFM considers metformin to be a “reasonable and safe first-line pharmacologic alternative to insulin”

More data is needed to establish long-term safety of oral agents

Glyburide has been associated with adverse neonatal events, such as macrosomia and hypoglycemia but SMFM also acknowledges that “the evidence of benefit of one oral agent over the other remains limited”

SMFM does acknowledge that their statement conflicts with ACOG, however

…this difference is based on the values placed by different experts and providers on the evidence available in the medical literature and is not meant to represent an exclusive course of management.

KEY POINTS:

Other ACOG Updates

One abnormal values on the 3 hour OGTT

In the previous 2017 practice bulletin, while it was clearly stated that diagnosis of GDM is based on 2 abnormal values on the 3 hour OGTT, ACOG seemed to suggest that one abnormal value may be sufficient to make the diagnosis

In the updated 2018 version, ACOG has clarified that statement

One abnormal glucose level may warrant a higher level of scrutiny, but is not sufficient for diagnosis

More studies are required to determine risk of adverse outcomes and who would benefit from making this a diagnostic criteria

Clarification of insulin use and dosage

ACOG has clarified the previous practice bulletin and now states that in women who have abnormal postprandial and fasting glucose levels

Insulin starting dose is 0.7-1.0 units/kg daily

Dosage should be divided and long-acting or intermediate-acting insulin in combination with short-acting insulin should be used

Previously, the 2017 documented stated that insulin was ‘first line’ therapy and the updated document now says ‘preferred’

ACOG recognizes that clinicians may assess the clinical circumstances and find the use of oral agents to be a better alternative in women (e.g., patient cannot afford insulin or feel administering the drug would be unsafe)

Macrosomia and cesarean section

The recommendation that women with GDM should be counseled about the risks/benefits of a scheduled cesarean section if the estimated fetal weight is ≥4,500 g has been moved from ‘limited or inconsistent scientific evidence’ (Level B) to ‘consensus and expert opinion’ (Level C)

Disclosure of Unlabeled Use

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Disclaimer

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

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